StrokeNCT05293951
Mirror Aided Cross Education in Post Stroke Upper Limb Rehabilitation.
A study testing Mirror Strengthening Device and Mirror Therapy in people with Stroke, run by Institute of Technology, Sligo at 1 site in Ireland.
Trial summary
This is a pilot randomised controlled trial investigating a combination of mirror therapy and cross-education training compared to mirror therapy alone for the rehabilitation of upper limb impairment following a stroke. A case study series will be completed in advance of the full randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mirror Strengthening Device and Mirror Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- 1 Nov 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ischemic or hemorrhagic stroke as determined by a stroke neurologist. Stroke will be defined as an acute event of cerebrovascular origin causing focal or global neurologic dysfunction lasting more than 24 hours diagnosed by a neurologist/gerontologist, and confirmed by computed tomography or magnetic resonance imaging.
- ≥3 months post stroke; with no restrictions on how long post stroke.
- Discharged from formal physiotherapy rehabilitation services.
- Unilateral upper limb weakness with a Medical Research Council (MRC) Scale for Strength score greater than 2 (i.e., movement with influence of gravity removed) in the limb to be assessed and treated.
- Functional active range of movement and power in non-hemiparetic side.
- Ambulatory with or without use of a walking device. Must be able to transfer into the Biodex machine.
- Older than 18 yrs.
- Not involved in any other type of structured strength training for the duration of the study.
Who cannot join
- Diagnosis of additional neurological condition (including more than one stroke) or cardiovascular disease.
- Presence of musculoskeletal conditions affecting the bones and/or soft tissues of the upper extremity.
- Impaired cognition that would affect ability to informed consent (MMSE <21).
- Presence of aphasia or visual impairments.
- Medications affecting tone less than 3/12 prior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Potential Effectiveness of Mirror Aided Cross Education Using the Innovative 'Mirror Strengthening Device' Compared to Mirror Therapy Alone in Post Stroke Upper Limb Rehabilitation: A Pilot Randomised Feasibility Study.
This is a pilot randomised controlled trial investigating a combination of mirror therapy and cross-education training compared to mirror therapy alone for the rehabilitation of upper limb impairment following a stroke. A case study series will be completed in advance of the full randomised controlled trial.
The outcome measure assessments will take place at the institution. All intervention therapy sessions will be completed by the participant in their own home with the first introductory session being completed with the lead researcher. The study will be conducted in conjunction with Sligo University Hospital once it has attained ethical approval through the relevant University Hospital Ethics Committee.
Read the detailed description
The study will require participants with chronic stroke to perform an upper limb Home Exercise Program (HEP) in their own home.
INTERVENTION:
Experimental Group Experimental participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will pull a resistance cord with their non-affected arm, while looking at its reflection in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device.
Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). The initial resistance will be chosen based on the participant's initial outcome measure results.
Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
Control Group
Control participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will be watching their non-affected arm reflected in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device. Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
Positioning
- Participants will be seated in a chair in front of a table in their own home.
- The untrained limb will be positioned in a similar position to the training limb supported on the table behind the exercise device with the shoulder slightly flexed forward to allow this positioning.
Training duration \& frequency
-20-30 minutes, 5/week for 4 weeks = total 20 sessions. Based on the average length and frequency of interventions in studies reported by a Cochrane Review for mirror therapy and the duration of 2 similar previous studies involving unilateral strengthening.
Compliance:
The participants will be provided with an exercise diary in which they will record when they completed their exercises and how many repetitions they completed. If they did not complete their exercises there will be space to explain why not. They will also be sent a reminder text message by the lead researcher (Claire Smyth) on the proposed day of their exercises as a prompt/reminder.
Block Randomisation
The Design is an assessor-blinded, randomised control trial. The assessor, who is blinded to the treatment assignment will perform all the assessments After baseline measurements are obtained, the patients will be randomly assigned to the intervention or control group using computer-generated block random numbers where gender and function (based on the Fugl Meyer Upper Extremity Test) will be considered.
A statistician who will be blinded to the research protocol and not otherwise involved in the trial will conduct the random number programme. The assignment of patients to experimental and control groups will be contained in opaque sealed envelopes that will be numbered 1-24 and the principle researcher will only inform each participant what group they are in post-baseline testing.
Adverse Effects:
Record any changes before and after each training session in the HEP record book Contact the Principal Researcher
- Conditions
- Stroke
- Being tested
- Mirror Strengthening Device, Mirror Therapy
- Keywords
- Mirror Therapy, Cross-education Therapy, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Strengthening DeviceDevice
Participants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm.
The initial resistance will be chosen based on the participants initial outcome measure results.
Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.
Mirror TherapyDevice
Participants will perform non-resisted task-specific upper limb exercises. During the exercises, participants will be watching their non affected arm reflected in a mirror covering their affected arm.
Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy + Cross Education | Experimental | Cross Education: Experimental participants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Mirror Therapy: Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm.
Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions. Receives: Device: Mirror Strengthening Device |
| Mirror Therapy Alone | Active comparator | Mirror Therapy: Control participants will perform non-resisted task-specific upper limb exercises. Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm.
Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions. Receives: Device: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Upper Limb Strength
(Biodex System 4 Pro with advantage software) IPRS Limited, Suffolk House, Bramford Road, Little Blakenham, Suffolk, IP8 4JU. A higher score indicates more strength.
Measured: 4 weeks.
Secondary outcomes (4)
Upper limb range of movement.
Goniometer placed with centre over joint axis and each arm aligned with the measuring limbs.
Range 0-180 degrees with a higher score indicating more range of motion.
Measured: 4 weeks.
Modified Ashworth Scale (MAS) for spasticity.
Passive movement of each limb and joint movement carried out by the investigator.
Scale is 0-5. A higher score indicates higher levels of spasticity/tone.
Measured: 4 weeks.
Stroke Impact Scale measures Handicap.
Self reported questionnaire that evaluates disability and health related quality of life after stroke.
The scale contains 59 questions which are answered on a scale of 1-5. A higher score indicates better function.
Measured: 4 weeks.
Fugl Meyer Upper Extremity Test
A stroke specific performance based impairment index. The Test assesses 5 domains using a 3 point scale where a higher score again indicates more function.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Nov 2022
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomised Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Technology, Sligo
- Sponsor type
- University, hospital or other
- Collaborators
- Sligo General Hospital
- Responsible party
- Principal investigator, Kenneth Monaghan, Institute of Technology, Sligo
- Investigators
- Claire Smyth, BSc, Principal investigator, Institute of Technology, Sligo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293951
- Sponsor's protocol ID
- ITSligo NRG
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be held in coded unidentifiable files on the principle investigators computer which is password protected. If needed for systematic review analysis at a later date this data can be provided to other researchers without any issues involved or without patient personal information being identified. We will only provide necessary data required.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Potential Effectiveness of Mirror Aided Cross Education Using the Innovative 'Mirror Strengthening Device' Compared to Mirror Therapy Alone in Post Stroke Upper Limb Rehabilitation: A Pilot Randomised Feasibility Study.
- ClinicalTrials.gov ID
- NCT05293951
- Acronym / sponsor ID
- ITSligo NRG
- Conditions
- Stroke
- Keywords
- Mirror Therapy, Cross-education Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Institute of Technology, SligoUniversity, hospital or other
- Collaborators
- Sligo General Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot randomised controlled trial investigating a combination of mirror therapy and cross-education training compared to mirror therapy alone for the rehabilitation of upper limb impairment following a stroke. A case study series will be completed in advance of the full randomised controlled trial.
The outcome measure assessments will take place at the institution. All intervention therapy sessions will be completed by the participant in their own home with the first introductory session being completed with the lead researcher. The study will be conducted in conjunction with Sligo University Hospital once it has attained ethical approval through the relevant University Hospital Ethics Committee.
Detailed description
The study will require participants with chronic stroke to perform an upper limb Home Exercise Program (HEP) in their own home.
INTERVENTION:
Experimental Group Experimental participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will pull a resistance cord with their non-affected arm, while looking at its reflection in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device.
Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). The initial resistance will be chosen based on the participant's initial outcome measure results.
Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
Control Group
Control participants will perform task-specific upper limb exercises while in a seated position at their kitchen table. During the exercises, participants will be watching their non-affected arm reflected in a mirror covering their affected arm. The untrained limb will be positioned in a similar position to the training limb, supported on the table behind the exercise device. Examples of the exercises include bringing the arm out to the side and up in the air (reaching style movement). Repetitions of these exercises will be prescribed according to patient function and strength and will be increased each week as their ability improves. Sessions will start with 20-minute durations and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes.
Positioning
- Participants will be seated in a chair in front of a table in their own home.
- The untrained limb will be positioned in a similar position to the training limb supported on the table behind the exercise device with the shoulder slightly flexed forward to allow this positioning.
Training duration \& frequency
-20-30 minutes, 5/week for 4 weeks = total 20 sessions. Based on the average length and frequency of interventions in studies reported by a Cochrane Review for mirror therapy and the duration of 2 similar previous studies involving unilateral strengthening.
Compliance:
The participants will be provided with an exercise diary in which they will record when they completed their exercises and how many repetitions they completed. If they did not complete their exercises there will be space to explain why not. They will also be sent a reminder text message by the lead researcher (Claire Smyth) on the proposed day of their exercises as a prompt/reminder.
Block Randomisation
The Design is an assessor-blinded, randomised control trial. The assessor, who is blinded to the treatment assignment will perform all the assessments After baseline measurements are obtained, the patients will be randomly assigned to the intervention or control group using computer-generated block random numbers where gender and function (based on the Fugl Meyer Upper Extremity Test) will be considered.
A statistician who will be blinded to the research protocol and not otherwise involved in the trial will conduct the random number programme. The assignment of patients to experimental and control groups will be contained in opaque sealed envelopes that will be numbered 1-24 and the principle researcher will only inform each participant what group they are in post-baseline testing.
Adverse Effects:
Record any changes before and after each training session in the HEP record book Contact the Principal Researcher
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy + Cross Education | Experimental | Device: Mirror Strengthening DeviceCross Education: Experimental participants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Mirror Therapy: Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions. |
| Mirror Therapy Alone | Active comparator | Device: Mirror TherapyMirror Therapy: Control participants will perform non-resisted task-specific upper limb exercises. Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of ischemic or hemorrhagic stroke as determined by a stroke neurologist. Stroke will be defined as an acute event of cerebrovascular origin causing focal or global neurologic dysfunction lasting more than 24 hours diagnosed by a neurologist/gerontologist, and confirmed by computed tomography or magnetic resonance imaging.
- ≥3 months post stroke; with no restrictions on how long post stroke.
- Discharged from formal physiotherapy rehabilitation services.
- Unilateral upper limb weakness with a Medical Research Council (MRC) Scale for Strength score greater than 2 (i.e., movement with influence of gravity removed) in the limb to be assessed and treated.
- Functional active range of movement and power in non-hemiparetic side.
Key exclusion criteria (5 listed)
- Diagnosis of additional neurological condition (including more than one stroke) or cardiovascular disease.
- Presence of musculoskeletal conditions affecting the bones and/or soft tissues of the upper extremity.
- Impaired cognition that would affect ability to informed consent (MMSE <21).
- Presence of aphasia or visual impairments.
- Medications affecting tone less than 3/12 prior.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror Strengthening DeviceParticipants will perform resisted task-specific upper limb exercises. During the exercises, participants will pull a resistance cord with their non-affected arm, Participants will complete the exercises while looking at its reflection in a mirror covering their affected arm. The initial resistance will be chosen based on the participants initial outcome measure results. Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions. | Device | Mirror Therapy + Cross Education |
| Mirror TherapyParticipants will perform non-resisted task-specific upper limb exercises. During the exercises, participants will be watching their non affected arm reflected in a mirror covering their affected arm. Repetitions of these exercises will be prescribed according to patient function and strength, and will be increased each week as their ability improves. Sessions will start with 20-minute durations, and should increase in length as the therapy progresses due to the increased repetitions, but are not expected to exceed 30 minutes. Training duration \& frequency: 20-30 minutes, 5/week for 4 weeks = total 20 sessions. | Device | Mirror Therapy Alone |
Primary outcome
Isokinetic Upper Limb Strength
Time frame: 4 weeks.
(Biodex System 4 Pro with advantage software) IPRS Limited, Suffolk House, Bramford Road, Little Blakenham, Suffolk, IP8 4JU. A higher score indicates more strength.
4 secondary outcomes
Upper limb range of movement.
Time frame: 4 weeks.
Modified Ashworth Scale (MAS) for spasticity.
Time frame: 4 weeks.
Stroke Impact Scale measures Handicap.
Time frame: 4 weeks.
Fugl Meyer Upper Extremity Test
Time frame: 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No. IPD will be held in coded unidentifiable files on the principle investigators computer which is password protected. If needed for systematic review analysis at a later date this data can be provided to other researchers without any issues involved or without patient personal information being identified. We will only provide necessary data required.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Smyth, BSc principal investigator
Institute of Technology, Sligo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Strengthening Device and Mirror Therapy in people with Stroke, run by Institute of Technology, Sligo at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Upper Limb Strength (time frame: 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.